Transcranial LED Therapy for Severe Acute Traumatic Brain Injury
NCT03281759 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2017-09-13
Summary
The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.
Conditions
- Diffuse Axonal Brain Injury
- Traumatic Brain Injury
Interventions
- DEVICE
-
Transcranial LED Therapy (Active coil helmet)
The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
- DEVICE
-
Transcranial LED Therapy (Inactive coil helmet)
The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.
Sponsors & Collaborators
-
University of Sao Paulo General Hospital
lead OTHER
Principal Investigators
-
Wellingson S Paiva, PhD · University of Sao Paulo General Hospital
-
Joao G Santos, MD · University of Sao Paulo General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-01
- Primary Completion
- 2018-10-01
- Completion
- 2018-12-01
Countries
- Brazil
Study Locations
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